Research and planning

Internal working document

This page is for internal planning only. It will not be included in the final response to BSI.

Context: Corrective action 4 and CAPA effectiveness

BSI frames this entire question around corrective action 4 from the original CAPA Plan (NCR 2650005-202501-N1). That corrective action stated:

"We will add to the IFU a section called 'User interface' explaining the UI elements that an ITP may develop for their users to interact. In this section, we will include a recommended way of displaying to users the information of the manufacturer and the intended use, according to Annex I, 17.2."

The actual implementation (per the CAPA Closeout) was:

"Implemented. IFU section 'User interface' at https://apidocs-draft.legit.health/docs/1.1.0.0/installation-manual/user-interface with UI guidelines for ITPs and recommended display of manufacturer info per MDR Annex I, 17.1."

BSI reviewed the User Interface section of the IFU (ifu.pdf, corresponding to apps/eu-ifu-mdr) and found the implementation incomplete.

CAPA effectiveness implication

BSI is not only assessing GSPR compliance -- they are also evaluating whether corrective action 4 was effectively implemented. The wording "effective implementation of corrective action 4 are not fully demonstrated" means BSI considers the CAPA insufficiently closed. Our response must explicitly acknowledge that corrective action 4 was insufficiently implemented and describe the remediation, because BSI tracks CAPA effectiveness across rounds.

GSPRs at stake:

• GSPR 23.1(a): The medium, format, content, legibility and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s).
• GSPR 23.1(f): Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation. (The subsequent implementing rules for MDR devices are Regulation (EU) 2021/2226.)
• GSPR 23.2: Lists 19 specific items (a through s) that must appear on the label.

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Question 1a: Sample label does not meet GSPR 23.2

What BSI is asking

The "sample label and instructions in installation instructions in the IFU, section User Interface" do not meet GSPR 23.2. BSI specifically lists missing items: name of the device, UDI, date of manufacture, intended purpose, indication the device is a medical device.

Relevant QMS documents and sections

File	What it contains	Relevance
apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/installation-manual/user-interface.mdx	The User Interface section BSI reviewed. Contains sample instructions, report components, and a simplified Label component. Lines 420-449 contain the "Label" subsection with explanatory text referencing GSPR 23.1 and the rendered <Label /> component.	Primary target of the NC. The Label component here (Label.tsx from @repo/ui) only shows: manufacturer logo, CE/BSI icon, caution icon, batch code/version, and "consult IFU" icon. It does NOT include: device name, UDI, manufacture date, intended purpose, or "Medical Device" indication. The explanatory text is vague -- it says "Ensure the UI provides clear identifying details" but does not enumerate which GSPR 23.2 items are required.
apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/general-information/label.mdx	The full label section of the IFU. Imports and renders the comprehensive Label component from @legithealth/reusable.	Contains ALL GSPR 23.2 required items. BSI may not have noticed this section adequately, or may consider it insufficient that the User Interface section doesn't match.
packages/ui/src/components/DiagnosticReportUi/Label.tsx	The simplified sample label shown in the User Interface section. Imports only 5 icons from medical-device-symbols: ManufacturerIcon, CeBsiIcon, CautionIcon, ConsultInstructionsForUseIcon, BatchCodeIcon.	This is the problem. It is a minimal UI sample showing only 5 symbols/items. It lacks: device name text, UDI, manufacture date, intended purpose, MD indication. Note: the medical-device-symbols package already provides MdIcon, UdiIcon, and ManufactureDateIcon -- these just need to be imported and rendered.
packages/reusable/snippets/Label.mdx	The full regulatory label used in the IFU's General Information > Label section.	This has everything. Device name, EMDN, GMDN, UDI ((01)8437025550005(10)1.1.0.0(11)YYYYMMDD), batch/version, manufacture date, manufacturer details, authorised representative, eIFU, caution, CE/BSI, Medical Device symbol, ANVISA, warnings, and JSON representation.
apps/qms/src/components/LabelingRequirements/labeling-requirements.json	27 labeling requirements (LR-xxx).	Key ones: LR-2GT (regulatory compliance symbols and CE marking on label), LR-4KV (manufacturer identification), LR-8HV (minimum UI requirements -- currently only covers display of probability distributions, clinical indicators, etc., and says nothing about label items).
apps/qms/docs/legit-health-plus-version-1-1-0-0/information-provided-by-the-manufacturer/R-TF-001-006-IFU-and-Label-Validation.mdx	IFU validation against GSPR 23.	Contains the validation checklist. Will need updating after fix to confirm the User Interface section now meets GSPR 23.2.
capa-plan-bsi-ce-mark-closeout.mdx, section "NCR 2650005-202501-N1"	Corrective action 4 details.	The original promise was to include "a recommended way of displaying to users the information of the manufacturer and the intended use, according to Annex I, 17.2."

Gap analysis: Systematic GSPR 23.2 applicability

GSPR 23.2 lists 19 sub-items (a through s). Not all apply to a software medical device. The table below analyses each one:

GSPR 23.2	Requirement	Applicable?	Present in full Label (Label.mdx)?	Present in sample Label (Label.tsx)?	Gap?
23.2(a)	Device name/trade name	Yes	Yes ("Legit.Health Plus")	No (only shows logo)	GAP
23.2(b)	Intended purpose (details for user to identify device)	Yes	Yes (via JSON output)	No	GAP
23.2(c)	Manufacturer name & address	Yes	Yes (full details)	Partial (logo + "Gran Vía 1, 48001, Bilbao, Spain")	Partial
23.2(d)	Authorised representative (if manufacturer outside EU)	N/A	N/A (manufacturer is in Bilbao, Spain -- within the EU)	N/A	N/A
23.2(e)	Medicinal substance / tissues / cells	N/A	N/A (software device)	N/A	N/A
23.2(f)	Information per Section 10.4.5	N/A	N/A (not applicable to software)	N/A	N/A
23.2(g)	Lot/serial number	Yes	Yes (version (10) 1.1.0.0)	Yes ("Version 1.1.0.0")	OK
23.2(h)	UDI carrier	Yes	Yes ((01)8437025550005(10)1.1.0.0(11)YYYYMMDD)	No (no UdiIcon or UDI text)	GAP
23.2(i)	Time limit for safe use	N/A	N/A (software does not expire in this sense; supported versions are documented elsewhere)	N/A	N/A
23.2(j)	Date of manufacture	Yes	Yes ((11) YYYYMMDD)	No (no ManufactureDateIcon)	GAP
23.2(k)	Special storage/handling conditions	N/A	N/A (software device)	N/A	N/A
23.2(l)	Sterile state indication	N/A	N/A (software device)	N/A	N/A
23.2(m)	Warnings/precautions	Yes	Yes (caution admonitions)	Partial (CautionIcon present, but no text)	GAP
23.2(n)	Single use indication	N/A	N/A (software device)	N/A	N/A
23.2(o)	Reprocessed single-use indication	N/A	N/A (software device)	N/A	N/A
23.2(p)	"Custom-made device"	N/A	N/A (not custom-made)	N/A	N/A
23.2(q)	"Medical device" indication	Yes	Yes (MdIcon symbol)	No (no MdIcon)	GAP
23.2(r)	Substances via body orifice / skin	N/A	N/A (software device)	N/A	N/A
23.2(s)	Serial number for implantable devices	N/A	N/A (software device)	N/A	N/A
CE marking with NB number	Per Article 20(1)	Yes	Yes (CeBsiIcon + text)	Yes (CeBsiIcon present)	OK
Consult IFU symbol	Per GSPR 23.1(h) / ISO 15223-1	Yes	Yes (eIFU symbol + text)	Yes ("Read the instruction manual")	OK

Summary of applicable items: 23.2(a), (b), (c), (g), (h), (j), (m), (q), plus CE marking and Consult IFU symbol = 10 applicable items.

Items with gaps in Label.tsx: 23.2(a), (b), (h), (j), (m) partial, (q) = 6 gaps (plus (c) is partial).

Root cause: The Label.tsx component in packages/ui was designed as a visual UI sample for ITPs to see what a label region might look like in their UI. It was never intended to be the regulatory label itself -- that is the full Label.mdx in the reusable package. However, BSI understandably expects a "sample label" in the installation instructions to demonstrate ALL required items, especially since corrective action 4 promised "a recommended way of displaying to users the information of the manufacturer and the intended use."

Response strategy

Action required (two parts):

Part 1: Update Label.tsx in packages/ui/src/components/DiagnosticReportUi/ to include ALL applicable GSPR 23.2 items. Specifically:

1. 23.2(a): Add device name ("Legit.Health Plus") as explicit text
2. 23.2(b): Add a brief intended purpose statement
3. 23.2(c): Keep manufacturer name & address (already present, but ensure full legal name "AI Labs Group S.L." is shown)
4. 23.2(h): Add UdiIcon and the UDI string (01)8437025550005(10)1.1.0.0(11)YYYYMMDD
5. 23.2(j): Add ManufactureDateIcon and manufacture date
6. 23.2(m): Add warning text alongside CautionIcon (not just the icon)
7. 23.2(q): Add MdIcon (Medical Device indication)

The medical-device-symbols package already exports MdIcon, UdiIcon, and ManufactureDateIcon -- these just need to be imported.

Note: the full Label.mdx is a regulatory label document (with translated content, admonitions, JSON output) -- it is not suitable as a UI sample component. The correct approach is to update Label.tsx to be a comprehensive visual sample.

Part 2: Update the "Label" subsection text in user-interface.mdx (lines 420-449) to:

• Enumerate the specific GSPR 23.2 items that ITPs must include in their UI label
• Make it clear which items are mandatory (not just "Ensure the UI provides clear identifying details")
• Reference the full regulatory label at IFU section "General Information > Label" for the complete specification

Response wording: Acknowledge that corrective action 4 was insufficiently implemented: the sample label in the User Interface section did not include all applicable GSPR 23.2 items. Explain that the full regulatory label already exists at IFU section "General Information > Label" with all required items. State that the User Interface section has been updated with: (1) a complete sample label showing all applicable GSPR 23.2 items, and (2) an explicit checklist of required label items for ITPs. Provide red-lined IFU.

Documents to update:

Document	Change
packages/ui/src/components/DiagnosticReportUi/Label.tsx	Add all applicable GSPR 23.2 items: device name, UDI with UdiIcon, manufacture date with ManufactureDateIcon, intended purpose, MdIcon, warning text
apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/installation-manual/user-interface.mdx	Update "Label" subsection text (lines 420-449) to enumerate specific mandatory GSPR 23.2 items for ITPs

Evidence to provide:

1. Red-lined IFU showing changes to the User Interface section (both the label component and the explanatory text)
2. A table mapping each BSI-cited gap to the specific change made
3. Reference to the existing full label at IFU section "General Information > Label" (already compliant)
4. Reference to the JSON output's label data (already includes all items)

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Question 1b: Instructions do not require eIFU link for users

What BSI is asking

The installation instructions do not require the installer (ITP) to provide users (HCPs) with a link to the eIFU website. BSI gives examples of acceptable methods: via the user interface, training, or email.

Regulatory basis

The eIFU is governed by:

• GSPR 23.1(f): "Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation."
• Regulation (EU) 2021/2226 (the "eIFU Regulation" for MDR devices), which replaced Regulation (EU) No 207/2012 for devices under MDR 2017/745. Article 4 sets out the conditions under which eIFU may be provided instead of paper, including that "the manufacturer shall ensure that [...] users are adequately informed about [...] how to access the electronic instructions for use."
• The IFU already cites Regulation (EU) 2021/2226, Article 5 in the "Request paper IFU" section. But the User Interface section (installation instructions for ITPs) does not reference this regulation or impose any eIFU access requirement.

For an API-only device where HCPs never interact with the manufacturer's software directly -- they interact through ITP-built interfaces -- the User Interface section is the critical location to mandate eIFU access. Without this requirement, ITPs have no obligation to surface the eIFU URL to HCPs, which means clinical users may never find the instructions for use.

Relevant QMS documents and sections

File	What it contains	Relevance
apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/installation-manual/user-interface.mdx	The User Interface section -- contains no explicit eIFU link requirement for ITPs.	Primary gap. Tells ITPs how to build a UI but never says "you must give HCPs access to the eIFU."
packages/reusable/snippets/Label.mdx	Full label with "Consult instructions for use" symbol and eIFU URL.	The eIFU URL appears here, but this is in a different IFU section ("General Information > Label"), not in the installation instructions.
packages/reusable/translations/en.json	Contains eIFU field: "Read the instructions before use https://apidocs.legit.health"	Shows the eIFU URL is embedded in device JSON output, but this is machine-readable, not an explicit instruction to ITPs.
apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/request-paper-ifu/index.mdx	"Request paper IFU" section with form and 7-day delivery timeframe. References Regulation (EU) 2021/2226, Article 5.	Demonstrates the paper IFU option exists and cites the correct regulation, but doesn't address BSI's point about the installer providing an eIFU link.
apps/qms/src/components/LabelingRequirements/labeling-requirements.json	LR-1RH: "eIFU accessibility information" -- specifies URL, browser compatibility, paper copy process.	The labeling requirement exists but is not enforced in the installation instructions.

Gap analysis

The User Interface section (user-interface.mdx) does NOT contain any explicit instruction telling ITPs that they must provide HCPs with a link to the eIFU website. The eIFU URL appears in:

• The full label (Label.mdx) -- via the "Consult instructions for use" symbol and the JSON output's eIFU field
• The JSON output that the device returns (machine-readable)
• The "Request paper IFU" section of the IFU

But the installation instructions (User Interface section) do not say: "The installer must ensure that the eIFU URL is accessible to clinical users." This is a genuine gap.

eIFU URL resolved

The eIFU URL inconsistency has been resolved. https://apidocs-draft.legit.health/ was used as a placeholder during pre-certification (the IFU should not be published at its final location before certification). The canonical URL is now https://ifu-eu-mdr.legit.health/, and the User Interface section and Label component have been updated accordingly. Remaining references in R-TF-001-006, en.json, Label.mdx, and the CAPA plan still need unification as part of secondary updates.

Response strategy

Action required: Add to the User Interface section (user-interface.mdx) an explicit requirement for ITPs, under or alongside the "Label" subsection:

1. Mandatory requirement: ITPs MUST ensure that clinical users (HCPs) can access the electronic Instructions for Use (eIFU)
2. Acceptable methods: Providing a link in the user interface, including it in user training materials, displaying it during onboarding, or communicating it via email
3. The canonical eIFU URL must be displayed or communicated to users
4. Regulatory basis: Reference Regulation (EU) 2021/2226 (conditions for providing eIFU) and GSPR 23.1(f)

Response wording: Acknowledge the gap. State that the User Interface section has been updated to include an explicit requirement for ITPs to provide users with access to the eIFU website, in accordance with Regulation (EU) 2021/2226 and GSPR 23.1(f). Describe the specific addition (mandatory requirement, acceptable methods, URL). Note that the eIFU URL is also embedded in the device JSON output's eIFU field and displayed in the full regulatory label. Provide red-lined IFU.

Documents to update:

Document	Change
apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/installation-manual/user-interface.mdx	Add explicit eIFU access requirement for ITPs with regulatory reference to Regulation (EU) 2021/2226 and GSPR 23.1(f)

Evidence to provide:

1. Red-lined IFU showing the new eIFU requirement in the User Interface section
2. Reference to existing eIFU information in the full label and JSON output
3. Reference to the "Request paper IFU" section demonstrating compliance with Regulation (EU) 2021/2226, Article 5

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BSI observation: GSPR 17.1 reference

What BSI is asking

BSI notes it is unclear why the installation instructions reference GSPR 17.1. The opening paragraph of user-interface.mdx reads:

"To help organisations in the process of developing a user interface, and to comply with Annex I, Article 17.1 of the MDR, this section outlines the key elements..."

Relevant QMS documents and sections

File	What it contains	Relevance
apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/installation-manual/user-interface.mdx	Contains the incorrect reference to "Annex I, Article 17.1."	The reference needs correction.
capa-plan-bsi-ce-mark-closeout.mdx, section "NCR 2650005-202501-N1"	Corrective action 4 originally referenced "Annex I, 17.2." The implementation changed this to "17.1."	Shows the origin of the confusion.
apps/qms/docs/legit-health-plus-version-1-1-0-0/GSPR/R-TF-008-001-General-Safety-and-Performance-Requirements-GSPR.mdx	Full GSPR compliance matrix.	Confirms GSPR 17.1 is about repeatability/reliability/performance of electronic systems, not labelling.

Gap analysis

This is incorrect:

• GSPR 17.1 = "Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their intended use." (Not about labelling or information supplied.)
• GSPR 17.2 = "Software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation." (Not about labelling either.)
• The original CAPA plan referenced "17.2" but the implementation changed this to "17.1".
• Neither is correct. This section is about information supplied with the device, which falls under GSPR 23 (Annex I, Chapter III, "Requirements regarding the information supplied with the device").

The reference to GSPR 17 likely originated from a misunderstanding during the original CAPA plan drafting, where the User Interface section was conflated with software design requirements rather than information supply requirements.

Response strategy

Action required: Change the opening paragraph of user-interface.mdx from:

"and to comply with Annex I, Article 17.1 of the MDR"

to:

"and to comply with the requirements regarding the information supplied with the device (Annex I, Chapter III of the MDR 2017/745)"

Note: the IFU is an external-facing document for ITPs and HCPs. Use the full regulatory citation ("Annex I, Chapter III of the MDR 2017/745") rather than the internal GSPR shorthand ("GSPR 23").

Response wording: Acknowledge the error. Explain that the reference to GSPR 17.1 was a drafting error inherited from the original CAPA plan (which referenced 17.2). Explain that GSPR 17.1 concerns repeatability, reliability and performance of electronic programmable systems, not information supplied with the device. The correct reference for the User Interface section is Annex I, Chapter III (GSPR 23), which governs information supplied with the device. The IFU has been corrected. Provide red-lined IFU.

Documents to update:

Document	Change
apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/installation-manual/user-interface.mdx	Fix GSPR reference in opening paragraph from "Annex I, Article 17.1" to "Annex I, Chapter III of the MDR 2017/745"

Evidence to provide:

1. Red-lined IFU showing the corrected reference

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Overall assessment

• Low risk. This is a minor NC about documentation presentation, not a fundamental compliance failure. The required information already exists in the IFU (full label at "General Information > Label", eIFU URL in JSON output and label) -- it just needs to be properly presented in the User Interface section that BSI reviewed.
• Straightforward fix. The primary changes are to one IFU section (user-interface.mdx) and one UI component (Label.tsx).
• CAPA effectiveness concern. BSI explicitly frames this around corrective action 4, meaning they are assessing whether the previous CAPA was effectively closed. The response must acknowledge the insufficient implementation and demonstrate remediation.
• Cascading updates required. The following documents need updating to reflect the changes and maintain consistency:

Summary of all documents to update

Document	Changes	Priority
packages/ui/src/components/DiagnosticReportUi/Label.tsx	Add all applicable GSPR 23.2 items: device name, intended purpose, UDI with UdiIcon, manufacture date with ManufactureDateIcon, MdIcon, warning text alongside CautionIcon	Done
apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/installation-manual/user-interface.mdx	(1) Fix GSPR reference in opening paragraph; (2) Update "Label" subsection text to enumerate mandatory GSPR 23.2 items for ITPs; (3) Add explicit eIFU access requirement with Regulation (EU) 2021/2226 reference; (4) Removed "Consequences of Missing Labeling" section (over-sharing risk)	Done
apps/qms/docs/legit-health-plus-version-1-1-0-0/information-provided-by-the-manufacturer/R-TF-001-006-IFU-and-Label-Validation.mdx	Update validation to confirm the User Interface section now meets GSPR 23.2 requirements	Done
apps/qms/docs/legit-health-plus-version-1-1-0-0/GSPR/R-TF-008-001-General-Safety-and-Performance-Requirements-GSPR.mdx	Verify GSPR 23.1(a) and 23.2 entries reference the updated User Interface section as evidence	Done

eIFU URL resolved

The canonical eIFU URL is https://ifu-eu-mdr.legit.health/. The User Interface section and Label component now use this URL. apidocs-draft.legit.health was a pre-certification placeholder.

Summary of all evidence to provide to BSI

1. Red-lined IFU showing all changes to the User Interface section:
   • Corrected GSPR reference in opening paragraph
   • Updated sample label with all applicable GSPR 23.2 items
   • New explanatory text enumerating mandatory label items for ITPs
   • New eIFU access requirement for ITPs
2. Gap-to-fix mapping table showing each BSI observation (1a items, 1b, and 17.1 observation) paired with the specific change made and the GSPR 23.2 sub-item addressed
3. Reference to unchanged sections that already contain the complete information:
   • IFU section "General Information > Label" (full regulatory label with all GSPR 23.2 items)
   • Device JSON output (machine-readable label data including eIFU URL)
   • IFU section "Request paper IFU" (Regulation (EU) 2021/2226, Article 5 compliance)

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Post-response review and corrections

After drafting the response and implementing the primary fixes, we reviewed the response from the perspective of the BSI auditor to identify weaknesses before submission. Two issues were identified and corrected.

Issue 1: Over-sharing — "Consequences of Missing Labeling" section removed

The initial IFU update included a "Consequences of Missing Labeling" subsection in the User Interface section (user-interface.mdx) that quoted MDR Article 16 about distributors/importers assuming manufacturer obligations if label information is missing. This was removed because:

1. BSI did not ask about this. The NC concerns GSPR 23.2 completeness and eIFU access, not the liability model for ITPs. Including unsolicited information about Article 16 risks opening a new line of questioning about the distribution model (e.g., "Are ITPs making the device available under their own name?", "What contractual arrangements ensure ITP compliance?").
2. Violates the "don't over-share" principle. Per our response guidelines, adding information beyond what is required can open new lines of questioning. This section added nothing to closing the NC.
3. Could be interpreted as shifting liability. An auditor might read this as an attempt to disclaim manufacturer responsibility by pushing label obligations onto ITPs via regulatory threat, which could raise concerns about the manufacturer's control over downstream labelling.

Action taken: The entire "Consequences of Missing Labeling" subsection (MDR Article 16 quote and accompanying text) was removed from user-interface.mdx. The "Source Code for Symbols" subsection that followed it was retained.

Issue 2: Secondary documents not updated — internal consistency risk

The primary fixes (Label.tsx, user-interface.mdx) were implemented but the cascading updates to secondary documents identified in the "Summary of all documents to update" table above were not initially performed. This creates a risk: if BSI reviews these documents during follow-up and finds them inconsistent with the changes described in our response, it becomes a new finding about document control.

Action taken: Both secondary documents were updated:

R-TF-001-006 IFU and Label Validation (apps/qms/docs/legit-health-plus-version-1-1-0-0/information-provided-by-the-manufacturer/R-TF-001-006-IFU-and-Label-Validation.mdx):

• Added a paragraph in the Label validation section noting that the IFU § User Interface section now includes a sample label demonstrating all applicable GSPR 23.2 items, a requirements table, and an explicit eIFU access requirement per Regulation (EU) 2021/2226.

R-TF-008-001 GSPR Matrix (apps/qms/docs/legit-health-plus-version-1-1-0-0/GSPR/R-TF-008-001-General-Safety-and-Performance-Requirements-GSPR.mdx):

• 23.1.a: Added reference to the User Interface section's sample label and requirements table in the evidence column.
• 23.1.f: Added reference to the eIFU access requirement for ITPs per Regulation (EU) 2021/2226.
• 23.2.a: Added reference to device name in User Interface section.
• 23.2.b: Added reference to intended purpose in User Interface section.
• 23.2.h: Added reference to UDI carrier in User Interface section.
• 23.2.j: Added reference to manufacture date in User Interface section.
• 23.2.m: Updated evidence to say "warning symbol with accompanying text" (previously described icon-only state) and added User Interface section reference. Also corrected product name reference to "the Instructions for Use" per QMS convention.
• 23.2.q: Added reference to MD symbol in User Interface section.

Remaining known issues (not blocking NC closure)

• eIFU URL inconsistency: R-TF-001-006 still references https://eifu.legit.health/ in the JSON evidence block (line 68). The canonical URL is https://ifu-eu-mdr.legit.health/. This pre-dates the NC and should be unified as a separate housekeeping task, but does not affect the NC response.
• Product name references in GSPR matrix: Several rows in R-TF-008-001 still use "Legit.Health Plus" in the evidence column (e.g., "Legit.Health Plus label", "Legit.Health Plus IFU"). Per QMS convention these should be "the device" / "the label" / "the IFU", but changing all instances is outside the scope of this NC response.